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Medeor Matrix is indicated for use in general surgical procedures for the reinforcement and repair of soft tissue where weakness exists including, but not limited to; defects of the thoracic wall, suture line reinforcement, and muscle flap reinforcement; hernia repair; soft tissue reconstructive procedures including plastic and reconstructive surgical applications; and for reinforcement of the soft tissues, which are repaired by suture anchors, including but not limited to, rotator cuff, patellar, Achilles, biceps, quadriceps and other tendons. The device is not intended to replace normal body structure or provide the full mechanical strength to support tendon repair of the rotator cuff, patellar, Achilles, biceps, quadriceps, or other tendons. Sutures, used to repair the tear, and sutures or bone anchors used to attach the tissue to the bone, provide biomechanical strength for the tendon repair. The device is intended for single use only.

The purpose of this submission is to add hydration with autologous bodily fluids to the labeling of the Medeor Matrix device. Medeor Matrix is a resorbable porcine-derived collagen surgical mesh intended for reinforcement of soft tissues where weakness exists. The device is supplied sterile in double-layer peel-open packages. The device is packaged either dry or hydrated with saline. The device can be hydrated with saline or autologous bodily fluids prior to implantation.

The Kensey Nash P1076 Collagen Dental Membrane is indicated for: - Simultaneous use of GBR-membrane and implants. - Augmentation around implants placed in immediate extraction sites. - Augmentation around implants placed in delayed extraction sockets. - Localized ridge augmentation for later implantation. - Alveolar ridge reconstruction for prosthetic treatment. - Filling of bone defects after root resection, cystectomy, removal of retained teeth. - Guided bone regeneration in dehiscence defects. - Guided tissue regeneration procedures in periodontal defects

The Kensey Nash (KN) P1076 Collagen Dental Membrane is a translucent, resorbable, rectangular collagen membrane sheet derived from bovine tissue. The KN P1076 Collagen Dental Membrane is intended for single-use and is sterilized by Ethylene Oxide.

Medeor™ Matrix is indicated for use in general surgical procedures for the reinforcement and repair of soft tissue where weakness exists including, but not limited to: defects of the thoracic wall, suture line reinforcement, and muscle flap reinforcement; urogynecological reinforcement (excluding transvaginal repair of pelvic organ prolaps) including but not limited to, rectal prolapse (excluding rectocele) using an abdominal approach, vaginal prolapse (excluding transvaginal repair of pelvic organ prolapse), reconstruction of the pelvic floor using an abdominal approach (excluding transvaginal repair of pelvic organ prolapse), hemia repair; soft tissue reconstructive procedures including plastic and reconstructive surgical applications, and for reinforcement of the soft tissues, which are repaired by suture or suture anchors, including but not limited to, rotator cuff, patellar, Achilles, biceps, quadriceps and other tendons. Medeor Matrix is not intended to replace normal body structure or provide the full mechanical strength to support tendon repair of the rotator cuff, patellar, Achilles, biceps, quadriceps, or other tendons. Sutures, used to repair the tear, and sutures or bone anchors used to attach the bone, provide biomechanical strength for the tendon repair. Medeor Matrix is intended for one time use.

Medeor™ Matrix is a resorbable porcine-derived collagen surgical mesh intended for reinforcement of soft tissues. The device is supplied sterile in double-layer peel-open packages. The product is either packaged dry (lyophilized) to be hydrated prior to use, or can be supplied prehydrated, packaged and sterilized in saline.

The Kensey Nash Fibrillar Collagen Dental Membrane is indicated for: - . Simultaneous use of Guided Bone Regeneration (GBR)-membrane and implants. - Augmentation around implants placed in immediate extraction sites. . - . Augmentation around implants placed in delayed extraction sockets. - Localized ridge augmentation for later implantation. . - . Alveolar ridge reconstruction for prosthetic treatment. - Filling of bone defects after root resection, cystectomy, removal of retained teeth. . - Guided bone regeneration in dehiscence defects. . - . Guided tissue regeneration procedures in periodontal defects

The Kensey Nash (KN) Fibrillar Collagen Dental Membrane is a translucent, resorbable, non-friable, rectangular collagen membrane sheet derived from bovine tissue. The KN Fibrillar Collagen Dental Membrane is intended for single-use and is sterilized by Ethylene Oxide.

The OuickCat™ Extraction Catheter is indicated for the removal of fresh, soft emboli and thrombi from vessels in the arterial system.

The QuickCat™ Extraction Catheter is a single use, disposable, dual lumen catheter with associated accessories consisting of a 30 ml. vacuum syringe, extension tubing with stopcock, and an independent 40-micron filter basket. The 145 cm working length and is compatible with 6F guiding catheters with an inner diameter (I.D.) > 0.068" (1.73 mm) and 0.014" (0.36 mm) diameter guidewires. The extraction lumen of the catheter facilitates removal of emboli and thrombi via the attached tubing assembly, stopcock and vacuum syringe. The atraumatic distal tip, which incorporates a radiopaque marker for visibility under fluoroscopy, provides for smooth passage in the arterial system. The catheter consists of three segments. The stiffer proximal segment and more flexible distal segments provide the required structural integrity and flexibility to navigate tortuous vasculature. The distal segment consists of a dual lumen to allow for "rapid exchange" attachment to the guidewire. The catheter's distal portion has a hydrophilic coating to enhance deliverability. A 40-micron pore filter basket is supplied to assist in filtering of blood and thrombotic material for visual or laboratory analysis.

The Kensey Nash Bioresorbable Surgical Mesh is to be used wherever temporary wound support is required, to reinforce soft tissues where weakness exists, or for the repair of hernia or other fascial defects that require the addition of a reinforcing or bridging material to obtain the desired surgical result. Tissue attachment to the bioresorbable surgical mesh is minimized in case of direct contact with the viscera.

The Kensey Nash Bioresorbable Mesh is a biodegradable surgical mesh for trauma and reconstructive surgical procedures involving soft tissues. The Kensey Nash Bioresorbable Mesh is available in various sizes and thickness for use in maintaining the relative position of healing tissues. The implants maintain the stability of soft tissues during the healing period and minimize the attachment of the device. The Kensey Nash Bioresorbable Mesh material is subsequently reabsorbed by the body once the soft tissues have healed. The implants are not intended for use where permanent implants are required.

CopiOs® Bone Void Filler, in combination with autologous blood products such as bone marrow, is intended for use only for filling bone voids or gaps of the skeletal system (i.e. extremities, pelvis and spine, i.e., posterolateral spine fusion procedures with appropriate stabilizing hardware) that are not intrinsic to the stability of the bone structure. These voids may be a result of trauma or creation by surgeon. CopiOs Bone Void Filler is intended to be gently packed into the void or gap and will resorb during the course of the healing process.

CopiOs® Bone Void Fillers are resorbable sponges or paste (hydrated powder discs), which are manufactured from calcium phosphate and Type I bovine dermal collagen. CopiOs® devices are gamma-sterilized for single use and supplied in 1cc. 5cc and 10cc volumes.

ThromCat™ Thrombectomy Catheter System is indicated for mechanical removal of thrombus from synthetic hemodialysis access grafts and native vessel dialysis fistulae.

ThromCat™ Thrombectomy Catheter System is a single-use, disposable device that performs percutaneous maceration and removal of thrombus and restoration of blood flow. The device consists of a 5.5 Fr infusion/extraction catheter, a DC-powered infusion/extraction pump, and an extraction line and bag. The stainless steel helix is enclosed within a radiopaque, atraumatic flexible tip and shaft, preventing direct contact with the vessel wall. The integrated pumps, tubing, and 150cm length catheter provide an infusion flow to "wash" the vessel, while simultaneously providing an extraction flow to remove thrombus.

CopiOs™ Bone Void Filler, in combination with autologous blood products such as bone marrow, is intended for use only for filling bone voids or gaps of the skeletal system (i.e. extremities, pelvis, spine) that are not intrinsic to the stability of the bone structure. These voids may be a result of trauma or creation by surgeon. CopiOs Bone Void Filler is intended to be gently packed into the void or gap and will resorb during the course of the healing process.

CopiOs™ Bone Void Fillers are resorbable rectangular sponges or powder discs manufactured from calcium phosphate and Type I bovine dermal collagen. CopiOsTM Paste, a compressed powder disc, forms a paste when mixed with autologous blood products using the supplied spatula. CopiOs™ devices are gamma-sterilized for single use and supplied in 1cc, 5cc and 10cc volumes.

The TriActiv FX® Embolic Protection System is indicated for use in conjunction with percutaneous coronary intervention (PCI), using a 7F guide catheter (without side holes), of diseased saphenous vein coronary bypass grafts ranging from 3.0mm to 5.0m in diameter. The TriActiv FX® Embolic Protection System is intended to protect the distal coronary vasculature by trapping and extracting thrombotic and atheromatous debris liberated during PCI. The safety and effectiveness of this device as an embolic protection system has not been established in the cerebral, carotid, or peripheral vasculature; native coronary arteries; or for treatment of patients with acute myocardial infarction.

The TriActiv FX® Embolic Protection System is a temporary balloon occlusion embolic protection device used during percutaneous coronary intervention of diseased saphenous vein grafts ranging from 3.0mm to 5.0mm in diameter. The device is comprised of four principal components: ShieldWire™ Balloon Guidewire ("balloon guidewire), ShieldWire™ Inflator ("inflator"), FX™ Catheter ("flush catheter"), and AutoStream™ Flow Control ("flow control"). There are also four subcomponents or accessories included in the TriActiv FX® Embolic Protection the Split Tube Introducer, Shieldwire™ Guidewire Plug and Installer, System: TriActiv® Flow Control Power Supply and TriActiv® Tuohy. All TriActiv FX® Embolic Protection System components are supplied sterile and for single use only with exception of the TriActiv® Flow Control Power Supply which is non-sterile and reusable. The balloon guidewire is advanced through the hospital-supplied 7F guide catheter (without sideholes) prior to percutaneous coronary intervention of a saphenous vein araft (SVG) and positioned just past the target lesion. The balloon is inflated with a medical grade carbon dioxide gas blend, creating a protected space between the quide catheter and the balloon. Once the balloon is inflated and vessel occlusion is confirmed, PTCA and/or stenting can be performed over the balloon guidewire. Immediately after intervention, the flush catheter is loaded on the balloon guidewire and advanced into the graft. With the flush catheter positioned just proximal to the balloon, the flow control delivers saline through the flush catheter to gently wash the vessel and remove any debris generated during the intervention through the guide catheter into a collection bag. The TriActiv FX® Embolic Protection System has been designed to extract at a greater rate than it infuses to prevent aortic embolization. Once the physician is satisfied with the amount of debris removed from the vessel, the protection balloon is deflated and the device is removed.